Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3212-54.

Reason: Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits

Code information: Lot #: 1103917A, Exp. Feb 2018; 1114192A, Exp. Apr 2018; 1125605A, Exp. Jun 2018; 1138897A, 1153171A, Exp. Aug 2018; 1156261A, Exp. Oct 2018; 1171595A, Exp. Nov 2018; 1179544A, Exp. Jan 2019; 1189531A, Exp. Mar 2019; 1211389A,Exp. May 2019; 1227468A, Exp. Jun 2019; 1231784A, 1232943A, Exp. Sep 2019.

Distribution pattern: Distributed nationwide within the United States